CompletedPhase 1

Safety, Tolerability and Pharmacokinetics of DKF-310 ( (Donepezil).

Randomized, Double-blind, Placebo-controlled, Single Ascending Dose Phase 1 Clinical Trial to Evaluate Safety, Tolerability and Pharmacokinetics of DKF-310 Intramuscular Injection in Healthy Male Volunteers

Lead sponsor

Dongkook Pharmaceutical Co., Ltd.

Asset

DKF-310

Listed sites

Recruiting sites

Enrollment

actual

Study population

Alzheimer’s disease

Key I/E criteria

•Age 19-50•Male

Primary endpoints

•AUC•Cmax

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

Org study IDDKF-310-P1

NCT IDNCT02695004

Timeline

Milestones

Study start2016-02 (month precision)

Study first posted2016-03-01estimated

Primary completion2017-03actual (month precision)

Study completion2017-03actual (month precision)

Last update posted2020-04-06actual

Assets

Drug assets

DKF-310

Study populations

Who this study enrolls

Alzheimer’s disease

Eligibility

Who can enroll

Minimum age19 Years

Maximum age50 Years

SexMale

Healthy volunteersAccepted

Inclusion criteria

•Men aged 19 to 50 years

•Body weight 55 to 90 kg and BMI 18.0 to 27.0

•Voluntarily signed the informed consent form

•Eligible according to the screening test results

•Available to follow up after drop-out

Exclusion criteria

•Clinically significant disorders or a medical history of hepatic, renal, neurological, respiratory, endocrine, hemato-oncologic, cardiovascular, urological and psychiatric diseases

•Hypersensitivity to donepezil, piperidine derivatives and other drugs

•SBP <100 mmHg or >150 mmHg, or DBP <60 mmHg or >100 mmHg

•Skin and muscle disorders or history of surgery at the injection site

•AST or ALT >1.5xULN; QT/QTcB interval >450 ms

•History or positive result of drug abuse

•Prescribed drugs or herbal medicines within 2 weeks, over-the-counter drugs or vitamins within 1 week

•Participated in other clinical trials within 3 months

•Donated whole blood within 2 months or apheresis within 1 month, or transfusion within 1 month

•Alcohol consumption >21 units/week

•Smoked >10 cigarettes/day within 3 months

•Caffeine-containing foods

•Not eligible due to other reasons at the investigator's discretion

Endpoints (2)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Safety / tolerability / PK

2 endpoints

Primary/protocol endpoint

AUC

Time frame:1056h

concentration, descriptive

Primary/protocol endpoint

Cmax

Time frame:1056h

concentration, descriptive

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2

Snapshot dateJuly 21, 2026

Endpoint classificationDelfa ADRD endpoint taxonomy

Results tableno registry results posted yet

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 21, 2026 snapshot.